Pilot randomised double-blind placebo-controlled trials of Wuzhuyu Decoction in relieving chemotherapy-induced nausea and vomiting of breast cancer

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Patients signed informed consent and voluntarily joined the study;
•2. Breast cancer was confirmed by pathology or Histocytology;
•3. Excluding chemotherapy contraindications, breast cancer patients who plan to receive intravenous chemotherapy drugs;
•4. At any time during the current chemotherapy regimen, although there were antiemetic drugs consistent with the guidelines, there was significant CINV. The specific criteria were: nausea and vomiting or the need for more than one supplementary antiemetic drug, and / or >= moderate nausea on the 5-level scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe);
•5. The patient's ECoG status was 0, 1 or 2;
•6. The researchers determined that the patient could be treated with Wuzhuyu decoction;
•7. Aged >=18 years;
•8. Life expectancy greater than or equal to 4 months;
•9. Willing and able to comply with all research requirements, including treatment, time and nature of assessment required, including diary, quality of life, urine test and any statutory blood test.

•1. Allergic to traditional Chinese Medicine;
•2. The researcher judged other conditions not suitable for inclusion in the study;
•3. Symptomatic primary or secondary central nervous system malignancies;
•4. Symptomatic gastrointestinal obstruction;
•5. Disease related nausea or vomiting, need daily antiemetic treatment;
•6. History of epilepsy or recurrent seizures;
•7. Schizophrenia, other psychosis, severe personality disorder, except depression associated with underlying illness;
•8. Patients who are pregnant, breast-feeding or lack of contraception. Women with fertility must have a negative pregnancy test 7 days before registration;
•9. Patients who participated in other clinical trials in recent 3 months.

发起方

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine